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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03455270
Other study ID # G1T48-01
Secondary ID 2017-004502-17
Status Completed
Phase Phase 1
First received
Last updated
Start date May 9, 2018
Est. completion date September 29, 2022

Study information

Verified date December 2022
Source G1 Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer. The study is an open-label design, consisting of 3 parts: dose-finding portion including food effect (Part 1), G1T48 monotherapy expansion portion (Part 2), and G1T48 in combination with palbociclib expansion portion (Part 3). All parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 184 patients may be enrolled in the study.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date September 29, 2022
Est. primary completion date September 29, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - For Part 1, postmenopausal women only - For Parts 2 and 3, any menopausal status - Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable to curative therapy - For Part 1, prior treatment with less than 4 prior lines of chemotherapy - For Part 2, prior treatment with less than 2 prior line of chemotherapy - For Part 3, prior treatment with no more than 1 prior line of chemotherapy - For Parts 1 and 2, prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer - For Part 3, prior treatment with no more than 1 prior line of endocrine therapies for metastatic breast cancer - For Parts 1 and 2, patients must satisfy 1 of the following criteria for prior therapy: - Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor - Progressed after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer - For Part 3, patients must satisfy 1 of the following criteria for prior therapy: - Received = 24 months of endocrine therapy in the adjuvant setting prior to recurrence or progression - Received = 6 months of endocrine therapy in the advanced/metastatic setting prior to progression - For Part 1, evaluable or measurable disease - For Parts 2 and 3, evaluable (approximately 25%) or measurable disease (approximately 75%) as defined by RECIST, Version 1.1 including bone-only disease - ECOG performance status 0 to 1 - Adequate organ function Exclusion Criteria: - For Part 3, prior treatment with CDK4/6 inhibitor, investigational oral SERDs or SERCAs in any setting - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Anticancer therapy within 14 days of first G1T48 dose or within 28 days for antibody-based therapy - Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow - Prior hematopoietic stem cell or bone marrow transplantation

Study Design


Intervention

Drug:
G1T48
oral SERD
Palbociclib
CDK 4/6 Inhibitor

Locations

Country Name City State
Belgium Institut Jules Bordet Brussels
Belgium UZ Leuven Leuven
Bulgaria MHAT for Womens Health - Nadezhda OOD Sofia
Georgia ARENSIA Exploratory Medicine LLC Tbilisi
Moldova, Republic of ARENSIA Exploratory Medicine Phase I Unit, The Institute of Oncology Chisinau
Netherlands VU University Medical Center Amsterdam
Netherlands University Medical Center Groningen Groningen
Netherlands Erasmus Medical Center Rotterdam
Ukraine Spizhenko Clinic Kiev
United States Beverly Hills Cancer Center Beverly Hills California
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Northwestern University - Feinberg School of Medicine Chicago Illinois
United States Sarah Cannon Research Institute at Tennessee Oncology Nashville Tennessee
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Stanford Women Cancer Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
G1 Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Georgia,  Moldova, Republic of,  Netherlands,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose Limiting Toxicity Cycle 1 Day -3 to Cycle 1 Day 28
Primary Recommended Phase 2 dose G1T48 alone and in combination with palbociclib; progression-free survival (PFS) 12 months
Primary Number of Treatment Related Adverse Event, including Abnormal Laboratory Events All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all patients receiving study drug(s) from the signing of the informed consent until 30 days after the last dose of study medication(s). 21 months
Secondary Tumor response based on RECIST, Version 1.1 G1T48 alone and in combination with palbociclib; 21 months
Secondary Effect of food on bioavailability of G1T48 Part 1, Cycle 1 Day -10 to Cycle 1 Day 1.
Secondary Pharmacokinetics of G1T48 and metabolites: Maximum Plasma Concentration (Cmax) Part 1, Cycle 1 Day -3 to Cycle 2 Day 1. Part 2, Cycle 2 Day 1 to Cycle 3 Day 1. Part 3, Cycle 2 Day 1 to Cycle 3 Day 1.
Secondary Pharmacokinetics of G1T48 and metabolites: Area under Curve - plasma concentration (AUC) Part 1, Cycle 1 Day -3 to Cycle 2 Day 1. Part 2, Cycle 2 Day 1 to Cycle 3 Day 1. Part 3, Cycle 2 Day 1 to Cycle 3 Day 1.
Secondary Pharmacokinetics of G1T48 and metabolites: Plasma: terminal half life (T1/2) Part 1, Cycle 1 Day -3 to Cycle 2 Day 1. Part 2, Cycle 2 Day 1 to Cycle 3 Day 1. Part 3, Cycle 2 Day 1 to Cycle 3 Day 1.
Secondary Pharmacokinetics of G1T48 and metabolites: Plasma - Volume of distribution Part 1, Cycle 1 Day -3 to Cycle 2 Day 1. Part 2, Cycle 2 Day 1 to Cycle 3 Day 1. Part 3, Cycle 2 Day 1 to Cycle 3 Day 1.
Secondary Pharmacokinetics of palbociclib: Plasma - Trough concentration Part 3, Cycle 2 Day 1 to Cycle 3 Day 1.
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